This issue of Consultant Connection takes you behind the scenes to the Roundtable of Toxicology Consultants (RTC) meeting that was held prior to the 2015 American College of Toxicology (ACT) annual meeting in Nevada in November.
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In his key address, Dr. Sausen shared a few of the most pressing issues, discussed key emerging trends and offered advice regarding drug development today, including best practices and tips for consultants to leverage with their clients:
Development of a target product profile (TPP) “Starting with the end in mind is all about helping your clients define where they want to go — upfront,” shared Dr. Sausen. By first defining clinical and commercial success factors, a TPP can help you develop a common plan of attack for your clients. It provides a clear line-of-sight for a valuable molecule, improves decision-making to help reach critical milestones earlier and entices potential partners.
Industry trends for companion diagnostics (CDx) “Approximately 25 CDx applications are in clinical use today. As such, companion diagnostics can no longer be a nice-to-have,” said Dr. Sausen. “The fact is that we are seeing more biotech organizations integrate their CDx strategy during early clinical development.” As a consultant, this approach can help differentiate the consulting service you provide your clients by putting together a more robust application, thereby adding value through a differentiated molecule strategy. Consider recommending CDx development alongside your client’s primary therapeutic indication when patient-targeting profiles are a strategy.
Regulatory considerations “We are seeing decreases of up to 18 to 24 months off1 clinical development timelines when presubmission regulatory meetings are held,” shared Dr. Sausen. “Large pharma successfully employs this approach on a regular basis and biotech companies can gain efficiencies from utilizing this strategy.” Several valuable tactics, including establishing reimbursement meeting plans and talking through how to gain the most out of pre-IND meetings for improving clinical development times, were discussed.
Dual-filing strategies “Global study timelines can be reduced (possibly by multiple years) through proactive dual-filing planning and carefully executed studies,” said Dr. Sausen. He discussed new models of thinking when it comes to submitting filings and shared an example for the United States and China where six to nine months could be saved, changing the game in the global introductions of drugs.
The crucial role of stakeholders “An effective product value proposition includes evidence-based data that addresses the needs of multiple stakeholders and effectively communicates the product’s key differentiators,” explained Dr. Sausen. He shared the importance of evidence, including clinical, humanistic and economic value statements, in a strong value proposition, and discussed the role of the Global Value Dossier in creating a formal written strategy for communicating easily with stakeholders.
By beginning with the end in mind, we can work together to help your client develop a stronger product in today’s competitive and complex marketplace.
1. Vu et al., Thera Innov & Reg Sci, 2015, 49(3) 434.
“Because clients are faced with the reality that less than 1% of drugs make it to market, we’re increasingly seeing consultants serve as a key resource for helping biotech organizations gain efficiencies and experience to improve their odds of success in their development programs,” said Covance’s Peter Sausen, PhD, DABT, Vice President of Global Early Phase Development Solutions, during his presentation to the RTC. “In fact, our clients often ask us for names of independent consultants and are working with a growing number of consultants on drug development programs. It’s an important space for us to collaborate.”